Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects and Subjects With Chronic Liver Disease


Tracking Information

Start Date  ICMJEDecember 2008
Estimated Primary Completion DateMarch 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 28, 2008)		Blood samples [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00781430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 28, 2008)		Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy Evaluating The PK And Safety Of Neratinib In Healthy Subjects and Subjects With Chronic Liver Disease
Official Title  ICMJEAn Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of Neratinib in Subjects With Chronic Hepatic Impairment and in Matched Healthy Adults
Brief Summary

The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.

Detailed Description 
Study PhasePhase I
Study Type  ICMJEInterventional
Study Design  ICMJEOther, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Condition  ICMJEHepatic Insufficiency
Intervention  ICMJEDrug: Neratinib (HKI-272)
Study Arms / Comparison Groups1: Experimental
Intervention: Drug: Neratinib (HKI-272)

Recruitment Information

Estimated Enrollment  ICMJE27
Estimated Completion DateMarch 2009
Estimated Primary Completion DateMarch 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria for both study populations:

  1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.

    WONCBP may be included if they are either surgically sterile (hysterectomy or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone [FSH] level ≥ 38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article.

  2. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
  3. Have a high probability for compliance with and completion of the study.

Exclusion criteria for both study populations:

  1. Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death.
  2. Presence or history of any disorder that may prevent the successful completion of the study.
  3. History of drug abuse within 1 year before study day 1.

Other inclusion and exclusion criteria apply.

GenderBoth
Ages18 Years to 65 Years
Accepts Healthy VolunteersYes
Contacts  ICMJE
Contact: Trial Managerclintrialparticipation@wyeth.com
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00781430
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study ID Numbers  ICMJE3144A1-1111
Study Sponsor  ICMJEWyeth
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorWyeth
Information Provided ByWyeth